FDA 510(k), K163549, ClotTriever Thrombectomy System
FDA 510(k), K163549, ClotTriever Thrombectomy System
Device Name: ClotTriever Thrombectomy System
Manufacturer: Eben Gordon
Device Classification Name: Peripheral Mechanical Thrombectomy With Aspiration
Regulation Number: QEW
Classification Product Code: KXA
Date Received: 12/16/2016
Decision Date: 02/16/2017
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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